{"active_ingredient":["Active ingredient Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg"],"dosage_and_administration":["Directions Follow dosage below or use as directed by a physician, do not take more than 6 doses in any 24-hour period. age dose adults and children 12 years and over 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours children 2 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours children under 2 years of age consult a physician"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"49%\"/> <col width=\"49%\"/> <tbody> <tr> <td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>age</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>dose</paragraph> </td> </tr> <tr> <td styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>adults and children 12 years and over</paragraph> </td> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>children 6 years to under 12 years</paragraph> </td> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>children 2 to under 6 years of age</paragraph> </td> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>children under 2 years of age</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>consult a physician</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20171010","id":"bf9c3eda-b806-457f-9f00-15f3384dbe36","inactive_ingredient":["Inactive ingredients Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate. Sodium Content: 4 mg/5 mL"],"indications_and_usage":["Uses Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive."],"keep_out_of_reach_of_children":["Keep Out of Reach of Children Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel Guaifenesin Oral Solution USP 300 mg/15 mL 5 Cups Bag"],"purpose":["Purpose Expectorant"],"set_id":"faeaa1ed-7e4f-47c5-af2a-5f7e3f0fdf17","spl_product_data_elements":["Guaifenesin Guaifenesin GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM CITRIC ACID MONOHYDRATE FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM"],"spl_unclassified_section":["Drug Information Guaifenesin Oral Solution USP Expectorant Sugar Free/ Alcohol Free","How Supplied Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms: NDC 0121-0744-04 (4 fl oz bottle), NDC 0121-0744-08 (8 fl oz bottle), NDC 0121-0744-16 (16 fl oz bottle), NDC 0121-1744-05 (unit dose cups of 5 mL, 10 x 10's), NDC 0121-1744-10 (unit dose cups of 10 mL, 10 x 10's), and NDC 0121-1744-15 (unit dose cups of 15 mL, 10 x 10's)."],"storage_and_handling":["Storage Keep tightly closed. Store at controlled room temperature 20°-25° C (68°-77° F). [See USP] Protect from light. Pharmaceutical Associates, Inc. Breenville, SC 29605 R06/06"],"version":"3","warnings":["Warnings Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. • you are hypersensitive to any of the ingredients. If pregnant or breast-feeding, ask a health professional before use. Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillymandelic acid (VMA)."]}